R-009-001 BR J&J 20250822

• Deal Id: 42420020309

Goals

Goals for the 1^st year

The customer implements Legit.Health's medical device to achieve the following goal(s):

Goal	Metric	Target
AI support for dermatologic AE detection and severity assessment	Integration	100%
Evaluate the usability and acceptance of the AI solution in oncology practice	Clinical Utility Questionnaire (CUS)	70%
Evaluate the satisfaction with the AI solution in oncology practice	Customer Satisfaction Survey (CSAT)	75%

License terms and usage specifications

• Integration Type: Iframe

• Validity:

  • Phase 1: 3 months, 1 hospital with 15 oncologists. Q1 2026.
  • Phase 2: 12 months, 3 hospitals with 30 oncologists. 2026-2027.

• License Extension: In case a higher number of uses is needed due to increased demand, the possibility to extend the license will be available.

Project timeline and milestones

To achieve the goals, the parties agree on the following timeline.

Phase I: Hospital-level implementation timeline

To achieve the goals, the parties agree on the following timeline.

Phase II: Hospital-level implementation timeline

To achieve the goals, the parties agree on the following timeline.

Q&A to understand the Customer's Objective

Project Scope & objectives

Question	Expected Answer / Instructions	Customer's Answer
What is the primary objective of this project?	e.g., [ ] Quality control of images received in teledermatology [ ] Support for Primary Care diagnosis [ ] Support for Dermatology diagnosis [ ] Support for HCP in automatic severity measurement [ ] Support for patients in automatic severity measurement [ ] Appropriateness of referrals [ ] Clinical validation [ ] Improve diagnosis [ ] HCP satisfaction [ ] Operational efficiency [ ] Other
Do you want your users to interact with Legit.Health’s solution through your own software?	[ ] Yes [ ] No [ ] Not sure yet
Which features do you need? (you can select multiple)	[ ] Image quality analysis [ ] Diagnostic support [ ] Automatic severity assessment [ ] Other
Which conditions/pathologies are you interested in evaluating?	List of dermatological conditions relevant to your project e.g., [ ] Inflammatory Diseases [ ] Infectious Diseases [ ] Autoimmune Diseases [ ] Genodermatoses [ ] Vascular Diseases [ ] All [ ] All but with focus on x, y, z.	Psoriasis
Which languages do you need the solution to support?	English	EN
Do you already have a project definition?	[ ] Yes [ ] No [ ] In progress

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Technical Setup & Integration

Question	Expected Answer / Instructions	Customer's Answer
What type of integration do you need? (you can select multiple)	[ ] I will send images programmatically and need results in JSON format [ ] I need a UI for uploading images [ ] I need a UI to display results [ ] Sync with internal database
Do you plan to integrate Legit.Health into your own software platform?	[ ] Yes [ ] No [ ] Other
Who will upload the images to Legit.Health?	[ ] Healthcare professional [ ] Patient [ ] Both [ ] Other
How would you like to receive the Legit.Health results?	[ ] JSON [ ] PDF [ ] Web interface [ ] Other
Who will access to the Legit.Health results?	[ ] Healthcare professional [ ] Other (Patient)

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Timeline & Users

Question	Expected Answer / Instructions	Customer's Answer
When would you like to start the integration and go live?	Estimated date (YYYY-MM-DD)	Service deployment date: 2026 Q1
Estimated duration of the project	In months or years	Phase I: 3 months Phase II: 12 months
How many HCP will use the solution?	Estimated number	Phase I: 1 hospital with 15 HCP (10 oncologists and 5 dermatologists) Phase II: 3 hospitals with 30 HCP (20 oncologists and 10 dermatologists)
How many patients do you estimate will use the solution?	Estimated number
Number of medical centers involved	Estimated number	Phase I: 1 hospital Phase II: 3 hospitals
Estimated number of diagnostic reports per month	Approximate volume

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Comments & Open Questions

Question	Expected Answer / Instructions	Customer's Answer
Do you foresee any challenges we should be aware of?	e.g., Internal resources, approvals, data access
General comments or questions	Open field

Customer's Objective Summary

• Primary Objective:
• Integration Type:
• Features Needed:
• Conditions of Interest:
• Languages Supported: English
• Project Definition: TBD
• Integration Needs:
• Timeline: Service deployment date: 2026-01
• Other comments:

Technical analysis and details

This section provides technical specifications and implementation guidelines for developers working on the Oncoderm AE project integration.

System Architecture

Key Technical Components:

1. Iframe Integration: Maintains existing UI functionality while adding CTCAE support
2. ML Models: Analyze images and determine dermatologic condition type
3. Scoring Systems: Calculate severity based on specific metrics (ASALT, ALADIN, APASI, ASCORAD)
4. CTCAE Mapping Engine: Maps Legit.Health outputs to CTCAE v5.0 terms and grades using J&J mapping file
5. Multi-language Support: EN/PT localization throughout the interface
6. ExtraData Handling: Collects all required parameters even when not used in scoring
7. Comprehensive Output: UI display and PDF export with complete CTCAE information

User Stories

Healthcare Professional Stories

• US-001: As an HCP, I want the Iframe to function as it currently does as UI. This includes image upload, display of severity scores, and standard outputs, so that I can continue using the existing features without disruption.

• US-002: As an HCP, I want to upload an image and see the CTCAE results displayed in the UI (showing both CTCAE Term and CTCAE v5.0 equivalence with their respective values), so that I can quickly assess the adverse event severity.

• US-003: As an HCP, I want to see the CTCAE results in the exported PDF report (including CTCAE Term and CTCAE v5.0 equivalence values), so that I can document and share the assessment with the patient's care team.

• US-004: As an HCP, I want to access a documentation link within the Iframe interface that directs me to the GUIA DE BOLSO reference guide, so that I can reference the grading criteria when needed.

• US-005: As an HCP, I want to use the application in both Portuguese (PT) and English (EN) languages, so that I can work in my preferred language.

Developer Stories

• DEV-001: As a developer, I want the CTCAE results to be calculated using the following Legit.Health - CTCAE 5 Mapping file provided by J&J 20260109 New CTCAE Mapping for derm.ai pilot shared by J&J (003), so that the severity assessment aligns with J&J's clinical requirements.

• DEV-002: As a developer, I want the CTCAE results to be calculated for every uploaded image (regardless of diagnosis-support probability), so that we provide consistent assessment support across all cases.

• DEV-003: As a developer, I want the system to always prompt for user-provided clinical data (Body area, Surface area score, Pruritus, Sleeplessness) and pass unused parameters via extradata, so that we collect complete information for accurate CTCAE scoring and return in the pdf.

Customer/Stakeholder Stories

• US-008: As a Customer, I want access to a usage metrics report or dashboard, so that I can monitor adoption, utilization patterns, and ROI of the solution. Metrics derived from the solution’s outputs (anonymized and aggregated data): top-5, suspicion of malignancy, image quality, number of images uploaded, number of images rejected due to insufficient quality.

Required Input Parameters

The following parameters must be collected from the user for accurate CTCAE assessment:

Parameter	Type	Required	Description	Usage	Value/Example
Body Area	String	Yes (*)	Anatomical location of the adverse event		-
Surface Area Score	Number	Yes (*)	Percentage or score of affected body surface area	Scoring System calculation / extradata	0-100
Pruritus	Number	Yes (*)	Itching intensity (0-10 scale or categorical)	Scoring System calculation / extradata	0-10
Sleeplessness	Number	Yes (*)	Sleep disturbance level (0-10 scale or categorical)	Scoring System calculation / extradata	0-10

Note:

• Parameters marked with (*) are always required for user input. If not used in the scoring algorithm, they should be transmitted via extradata field for completeness.

Iframe Configuration Parameters

The following URL parameters must be configured in the Iframe integration:

Parameter	Type	Required	Description	Value/Example
forcedScoringSystems	string	Yes	Comma-separated list of scoring systems to be calculated regardless of ML output. Case-insensitive.	CTCAEv5 or CTCAEv5-DLQI (for multiple)

Implementation Notes:

• The forcedScoringSystems parameter should be passed as a URL parameter when embedding the Iframe to ensure that CTCAE-5 scoring is calculated for every image processed, providing consistent adverse event assessment across all cases.
• For multiple forced scoring systems, use comma-separated values: CTCAEv5-DLQI-PSI
• Parameter is case-insensitive: CTCAEv5, CtcaEv5, ctcaev5 are all valid
• Example Iframe URLs:
  • Single system: https://legit.health/iframe?forcedScoringSystems=CTCAEv5&lang=en
  • Multiple systems: https://legit.health/iframe?forcedScoringSystems=CTCAEv5-DLQI&lang=pt

Use Cases

Use Case	Input	Expected Output	Observed Output
UC-001: Forced Scoring Systems Config	Iframe loaded with URL parameter forcedScoringSystems=CTCAEv5	CTCAE-5 scoring calculated for all uploaded images regardless of ML confidence level	Pending
UC-002: Case-Insensitive Parameter	Iframe loaded with URL parameter forcedScoringSystems=CtcaEv5 (mixed case)	System correctly interprets parameter and calculates CTCAE-5 scoring (parameter is case-insensitive)	Pending
UC-003: Multi-language Support	HCP selects Portuguese language and uploads any dermatologic AE image	All UI elements, prompts, and CTCAE results displayed in Portuguese	Pending
UC-004: PDF Export with CTCAE	HCP completes assessment and clicks "Export PDF"	PDF report contains image, top-5, DIQA, severity scores, CTCAE Term, and CTCAE v5.0 equivalence	Pending
UC-005: Low Confidence Detection	HCP uploads an image where ML confidence is below standard threshold (e.g., 40% confidence)	CTCAE calculation still performed and results displayed with confidence indicator (due to forcedScoringSystems=CTCAEv5)	Pending
UC-006: Alopecia Assessment	HCP uploads an image showing alopecia with hair loss score = 25%	- Iframe output: asalt_local score = 25 - CTCAE Term: "Alopecia" - CTCAE v5.0 Grade 1 (0-50% = Grade 1)	Pending
UC-007: Alopecia Assessment - Severe	HCP uploads an image showing severe alopecia with hair loss score = 75%	- Iframe output: asalt_local score = 75 - CTCAE Term: "Alopecia" - CTCAE v5.0 Grade 2 (51-100% = Grade 2)	Pending
UC-008: Rash Acneiform - Mild	HCP uploads an image with acne lesion count = 5	- Iframe output: aladin_local, Number of acne lesions = 5 - CTCAE Term: "Rash acneiform" - CTCAE v5.0 Grade 1 (0-10 lesions = Grade 1)	Pending
UC-009: Rash Acneiform - Moderate	HCP uploads an image with acne lesion count = 20	- Iframe output: aladin_local, Number of acne lesions = 20 - CTCAE Term: "Rash acneiform" - CTCAE v5.0 Grade 2 (11-30 lesions = Grade 2)	Pending
UC-010: Rash Acneiform - Severe	HCP uploads an image with acne lesion count = 50	- Iframe output: aladin_local, Number of acne lesions = 50 - CTCAE Term: "Rash acneiform" - CTCAE v5.0 Grade 3 (31-100 lesions = Grade 3)	Pending
UC-011: Dry Skin - Desquamation Mild	HCP uploads psoriasis image with apasi_local desquamation score = 8	- Iframe output: apasi_local, Desquamation = 8 - CTCAE Term: "Dry Skin" - CTCAE v5.0 Grade 1 (0-10 = Grade 1)	Pending
UC-012: Dry Skin - Desquamation Moderate	HCP uploads psoriasis image with apasi_local desquamation score = 25	- Iframe output: apasi_local, Desquamation = 25 - CTCAE Term: "Dry Skin" - CTCAE v5.0 Grade 2 (11-30 = Grade 2)	Pending
UC-013: Dry Skin - Desquamation Severe	HCP uploads psoriasis image with apasi_local desquamation score = 60	- Iframe output: apasi_local, Desquamation = 60 - CTCAE Term: "Dry Skin" - CTCAE v5.0 Grade 3 (31-100 = Grade 3)	Pending
UC-014: Erythema Multiforme - Mild	HCP uploads image with apasi_local erythema score = 5	- Iframe output: apasi_local, Erythema = 5 - CTCAE Term: "Erythema multiforme" - CTCAE v5.0 Grade 1 (0-10 = Grade 1)	Pending
UC-015: Erythema Multiforme - Moderate	HCP uploads image with apasi_local erythema score = 20	- Iframe output: apasi_local, Erythema = 20 - CTCAE Term: "Erythema multiforme" - CTCAE v5.0 Grade 2 (11-30 = Grade 2)	Pending
UC-016: Erythema Multiforme - Severe	HCP uploads image with apasi_local erythema score = 50	- Iframe output: apasi_local, Erythema = 50 - CTCAE Term: "Erythema multiforme" - CTCAE v5.0 Grade 3 (31-100 = Grade 3)	Pending
UC-017: Dry Skin - Atopic Dermatitis	HCP uploads atopic dermatitis image with ascorad_local crusting = 15	- Iframe output: ascorad_local, Crusting = 15 - CTCAE Term: "Dry Skin" - CTCAE v5.0 Grade 2 (11-30 = Grade 2)	Pending
UC-018: Dry Skin - Dryness	HCP uploads image with ascorad_local dryness score = 8	- Iframe output: ascorad_local, Dryness = 8 - CTCAE Term: "Dry Skin" - CTCAE v5.0 Grade 1 (0-10 = Grade 1)	Pending
UC-019: Pruritus with Atopic Dermatitis	HCP uploads atopic dermatitis image with pruritus score = 7/10	- Iframe output: ascorad_local with Pruritus = 7 - CTCAE Term: "Pruritus" - CTCAE v5.0 Grade: TBD based on intensity mapping - Note: Pruritus collected as required parameter and included in extradata	Pending
UC-020: Complete SCORAD Assessment	HCP uploads atopic dermatitis image + inputs: BSA=30%, Pruritus=8, Sleeplessness=6	- Iframe output: ascorad_local with all parameters - Multiple CTCAE terms as applicable (Dry Skin, Erythema, Pruritus) - All required parameters (Body area, Surface area, Pruritus, Sleeplessness) captured	Pending

Testing Checklist

• Validate CTCAE calculation for all supported dermatologic AE types
• Test with images at varying confidence thresholds (20%, 40%, 60%, 80%)
• Verify all required parameters are collected via UI
• Confirm extradata transmission for non-scoring parameters
• Test language switching between EN and PT
• Validate PDF generation includes CTCAE fields
• Verify documentation link accessibility
• Load testing with concurrent users
• Edge cases: poor quality images, unusual body areas

Status and Follow-up Checkpoint

Task	Status	Expected Date	Final Date	Comments
✍️ Written	✅ Done	2026-01-29	2026-01-29	Technical specification fully documented
💬 Discussed in Meeting	⏳ Pending	2026-01-29	-	Scheduled for kickoff meeting
📋 Reviewed by CTO	⏳ Pending	YYYY-MM-DD	-	Awaiting technical architecture review by JD-007
✅ Approved by CTO	⏳ Pending	YYYY-MM-DD	-	Final approval required before development starts
🔄 Needs Changes or Adjustments	-	-	-	To be determined after CTO review
📋 Reviewed by CTO	⏳ Pending	YYYY-MM-DD	-	Awaiting technical architecture review by JD-007
✅ Approved by CTO	⏳ Pending	YYYY-MM-DD	-	Final approval required before development starts

Note: Using planka for task management and tracking (Backlog, To Do, Doing, Review, Done)

Project tasks

🧭 Definition & planning

Task	Description	Responsible	Status
Project conception and initiation	Initial ideation and opportunity scoping with all key stakeholders.	Deal Owner, JD-013	✅ Done
Definition and planning	Define project details: scope, key deliverables, timelines, success metrics, and required resources.	Deal Owner, JD-013	✅ Done
Implementation plan defined	Project scope, key deliverables, timelines, success metrics, and required resources are defined and clear	Deal Owner & JD-003 or JD-013 or JD-007	✅ Done

📝 Contracting

Task	Description	Responsible	Status
Offer Sent	Formal offer/proposal shared with the customer for review.	Deal Owner, JD-002	✅ Done
Offer Approved	Customer reviews and approves the proposed scope, terms, and pricing.		✅ Done
Contract Review	Align on deliverables, timelines, legal and data terms.		✅ Done
Contract Signing	Finalize and sign all contractual agreements.		✅ Done (2025-11-17)

🔌 Integration workflow

Task	Description	Timeline	Status	Dependencies
Technical onboarding	Provide comprehensive API documentation, technical walkthroughs, and UI/UX guidance for both patient and HCP views.	TBD	⏳ Pending	Kick-off meeting
API Access	After contract signed, generate and deliver API keys. Access to both production and testing environments.	TBD	⏳ Pending	Contract signed
Professional Services	Expert support from technicians, consultants, and project managers.. Review API input/output structures and align with UI mockups for surface input, scoring feedback, and reports.	TBD	⏳ Pending
Preproduction environment Testing	Validate integration in pre-prod using sample cases; assess scoring accuracy, latency, and input handling.	TBD	⏳ Pending	Interface mapping
Production environment Testing	Conduct final functional testing with production endpoints using real patient flows and edge cases.	TBD	⏳ Pending	Concordance validation
Launch Readiness & Go/No-Go	Final checklist review, rollback plan, support contact escalation paths, and stakeholder sign-off.	TBD	⏳ Pending	Optional, depending on work order
Customer service deployment into production	Officially deploy the service to production, ensuring all components are live and operational.	2026-03-01	⏳ Pending
Post-Launch Support & Tuning	Provide immediate support coverage, monitor usage patterns, and refine based on real-world feedback.	TBD	⏳ Pending

🚀 Project Execution

Task	Description	Responsible	Status
User Onboarding	Train stakeholders (e.g., medical teams, patients, HCPs) on the app and scoring system.	JD-021, JD-016	⏳ Pending
Customer Support Enablement	Setup and activate helpdesk or in-app support systems.	JD-021, JD-016	⏳ Pending
Data Analysis	Perform statistical and clinical analysis on severity scores and patient usage.	JD-021, JD-016, JD-014	⏳ Pending

🔁 Follow-up Meetings (Optional)

Task	Description	Responsible	Status
Follow-up Meeting	Formal review of key findings, feedback, and performance.	JD-021, JD-016	⏳ Pending
Interim Report	Summary report of current status, insights, and recommendations mid-project.	JD-021, JD-016	⏳ Pending

✅ Project Close

Task	Description	Responsible	Status
Final Report	Analyze final outcomes, compare against objectives, and document results.	JD-021, JD-016	⏳ Pending
Define Next Steps	Outline future roadmap, improvements, or additional collaborations.	JD-021, JD-016	⏳ Pending

Project leads

Team	Code	Leader of
Legit.Health	JD-002, JD-008, JD-019	Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager
Legit.Health	JD-027	Project Manager Lead
Legit.Health	JD-013	Project Manager
Legit.Health	JD-003	Design and Development Manager
Legit.Health	JD-016	Customer Success Manager
Legit.Health	JD-018	Clinical Research Manager
Legit.Health	JD-004	Quality Manager & PRRC
Legit.Health	JD-007, JD-010	Technology Manager, Software developer
Legit.Health	JD-005, JD-009	Machine Learning Manager, Medical Data Scientist
Legit.Health	JD-014	Data Analyst
Company Name	Name Surname	Project Director
Company Name	Name Surname	Project lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager

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Last updated: 2025-08-27